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Effect of Hydroxyurea on the Frequency of Painful Crises in Sickle Cell Anemia
Open accessAbstract
BACKGROUND: In a previous open-label study of hydroxyurea therapy, the synthesis of fetal hemoglobin increased in most patients with sickle cell anemia, with only mild myelotoxicity. By inhibiting sickling, increased levels of fetal hemoglobin might decrease the frequency of painful crises. METHODS: In a double-blind, randomized clinical trial, we tested the efficacy of hydroxyurea in reducing the frequency of painful crises in adults with a history of three or more such crises per year. The trial was stopped after a mean follow-up of 21 months. RESULTS: Among 148 men and 151 women studied at 21 clinics, the 152 patients assigned to hydroxyurea treatment had lower annual rates of crises than the 147 patients given placebo (median, 2.5 vs. 4.5 crises per year, P < 0.001). The median times to the first crisis (3.0 vs. 1.5 months, P = 0.01) and the second crisis (8.8 vs. 4.6 months, P < 0.001) were longer with hydroxyurea treatment. Fewer patients assigned to hydroxyurea had chest syndrome (25 vs. 51, P < 0.001), and fewer underwent transfusions (48 vs. 73, P = 0.001). At the end of the study, the doses of hydroxyurea ranged from 0 to 35 mg per kilogram of body weight per day. Treatment with hydroxyurea did not cause any important adverse effects. CONCLUSIONS: Hydroxyurea therapy can ameliorate the clinical course of sickle cell anemia in some adults with three or more painful crises per year. Maximal tolerated doses of hydroxyurea may not be necessary to achieve a therapeutic effect. The beneficial effects of hydroxyurea do not become manifest for several months, and its use must be carefully monitored. The long-term safety of hydroxyurea in patients with sickle cell anemia is uncertain.
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“inhibition of HbS polymerization with hydroxyurea reduces the incidence of ACS (205).”
From Pathophysiology of Sickle Cell Disease (2019) · cites this paper as [205]
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“By inducing increased levels of HbF through mechanisms that include suppressing erythropoiesis, hydroxyurea was first associated with reduction of morbidity and mortality in adults.81,82”
From Fetal hemoglobin in sickle cell anemia (2020) · cites this paper as [81]
Experimental — accuracy not yet measuredIn the citing paper
“Administration of hydroxyurea has been shown to induce expression of HbF, which interferes with the polymerization of HbS (33).”
From Red Blood Cell Function and Dysfunction: Redox Regulation, Nitric Oxide Metabolism, Anemia (2017) · cites this paper as [33]
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Brousseau, D. C., Richardson, T., Hall, M., Ellison, A. M., Shah, S. S., Raphael, J. L., Bundy, D. G., & Arnold, S. D. (2019) · PEDIATRICS · doi:10.1542/peds.2018-3285 · Cited by 60
Alberts, N. M., Badawy, S. M., Hodges, J., Estepp, J. H., Nwosu, C., Khan, H., Smeltzer, M. P., Homayouni, R., Norell, S., Klesges, L. M., et al. (2020) · JMIR mhealth and uhealth · doi:10.2196/14884 · Cited by 60
“Hydroxyurea induces fetal hemoglobin production, thereby decreasing sickle hemoglobin erythrocyte polymers, hemolysis, and vaso-occlusion [10,11].”
BackgroundNOVEL TREATMENT OPTIONS IN THE SEVERE β‐GLOBIN DISORDERS
Rodgers, G. P., & Rachmilewitz, E. A. (1995) · British Journal of Haematology · doi:10.1111/j.1365-2141.1995.tb05288.x · Cited by 60
Pediatric sickle cell disease: past successes and future challenges
Meier, E. R., & Rampersad, A. G. (2016) · Pediatric Research · doi:10.1038/pr.2016.204 · Cited by 59
Management of sickle cell disease
de Montalembert, M. (2008) · BMJ · doi:10.1136/bmj.a1397 · Cited by 59
Skin and nail changes in children with sickle cell anemia receiving hydroxyurea therapy
O’Branski, E. E., Ware, R. E., Prose, N. S., & Kinney, T. R. (2001) · Journal of the American Academy of Dermatology · doi:10.1067/mjd.2001.113471 · Cited by 59
Management of Sickle Cell Disease in Pregnancy
Sharma, R. (2012) · Apollo Medicine · doi:10.1016/j.apme.2012.07.002 · Cited by 59
Nietert, P. J., Silverstein, M. D., & Abboud, M. R. (2002) · PharmacoEconomics · doi:10.2165/00019053-200220060-00001 · Cited by 59
The pediatric hydroxyurea phase III clinical trial (BABY HUG): Challenges of study design
Thompson, B. W., Miller, S. T., Rogers, Z. R., Rees, R. C., Ware, R. E., Waclawiw, M. A., Iyer, R. V., Casella, J. F., Luchtman‐Jones, L., RANA, S. R., et al. (2009) · Pediatric Blood & Cancer · doi:10.1002/pbc.22269 · Cited by 59
Induction of Fetal Hemoglobin in Sickle Cell Disease
Bunn, H. F. (1999) · Blood · doi:10.1182/blood.v93.6.1787.406a34_1787_1789 · Cited by 59
Preoperative blood transfusions for sickle cell disease
Hirst, C., & Williamson, L. M. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003149.pub2 · Cited by 59
Haywood, C., Beach, M. C., Bediako, S. M., Carroll, C. P., Lattimer, L., Jarrett, D., & Lanzkron, S. (2010) · American Journal of Hematology · doi:10.1002/ajh.21883 · Cited by 58
Sickle Cell Disease: A Multigenic Perspective of a Single Gene Disorder
Kutlar, A. (2007) · Hemoglobin · doi:10.1080/03630260701290233 · Cited by 58
Rivers, A. E., Vaitkus, K., Ibanez, V., Ruiz, M. A., Jagadeeswaran, R., Saunthararajah, Y., Cui, S., Engel, J. D., DeSimone, J., & Lavelle, D. (2016) · Haematologica · doi:10.3324/haematol.2015.140749 · Cited by 56
Inherited thrombotic disorders: An update
Florell, S. R., & Rodgers, G. M. (1997) · American Journal of Hematology · doi:10.1002/(sici)1096-8652(199701)54:1 · Cited by 41
Increased soluble guanylate cyclase activity in the red blood cells of sickle cell patients
Conran, N., dos Santos, C. O., Acosta, H. C., Fattori, A., Saad, S. T. O., & Costa, F. F. (2004) · British Journal of Haematology · doi:10.1111/j.1365-2141.2004.04810.x · Cited by 58
Iyamu, E. W., Turner, E., & Asakura, T. (2003) · British Journal of Haematology · doi:10.1046/j.1365-2141.2003.04536.x · Cited by 59
The radiological manifestations of sickle cell disease
Madani, G., Papadopoulou, A. M., Holloway, B., Robins, A., Davis, J., & Murray, D. (2007) · Clinical Radiology · doi:10.1016/j.crad.2007.01.006 · Cited by 57
Sickle cell disease: time for a closer look at treatment options?
Sheth, S., Licursi, M., & Bhatia, M. (2013) · British Journal of Haematology · doi:10.1111/bjh.12413 · Cited by 57
“Prematurely discontinued because of overwhelming positive results (reduction in episodes of pain crises, ACS, and reduction in blood transfusions), this study established the effectiveness and safety of HC in adults (Charache et al, 1995).”
BackgroundBrousseau, D. C., McCarver, D. G., Drendel, A. L., Divakaran, K., & Panepinto, J. A. (2007) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2007.01.049 · Cited by 57
Chronic Transfusion Therapy for Children With Sickle Cell Disease and Recurrent Acute Chest Syndrome
Hankins, J. S., Jeng, M., Harris, S. C., Li, C., Liu, T., & Wang, W. C. (2005) · Journal of Pediatric Hematology/Oncology · doi:10.1097/01.mph.0000157789.73706.53 · Cited by 57
The association between sickle cell disease and dental caries in African Americans
Laurence, B., George, D., Woods, D., Shosanya, A., Katz, R. V., Lanzkron, S., Diener‐West, M., & Powe, N. R. (2006) · Special Care in Dentistry · doi:10.1111/j.1754-4505.2006.tb01430.x · Cited by 57
Metadata
- Authors
- Charache, S., Terrin, M. L., Moore, R. D., Dover, G. J., Barton, F. B., Eckert, S. V., McMahon, R. P., & Bonds, D. R.
- Affiliations
- Johns Hopkins University (US)
- Maryland Medical Research Institute (US)
- National Heart, Lung, and Blood Institute (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1995-05-18
- Volume
- 332
- Issue
- 20
- Pages
- 1317-1322
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2313541759
- Semantic Scholar
- 2c0939e2f6480b519903bb15870e5b894887e70d
- Cited by
- 2,340
- References
- 26
- Citations by year
- 2026: 67 · 2025: 97 · 2024: 77 · 2023: 88 · 2022: 95 · 2021: 92 · 2020: 80 · 2019: 78 · 2018: 85 · 2017: 104 · 2016: 114 · 2015: 101 · 2014: 82 · 2013: 79 · 2012: 73
- FWCI
- 34.43
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bristol-Myers Squibb
- National Institutes of Health (5u01hl045696-05)
- National Heart, Lung, and Blood Institute (UO1-HL 45696, UO1 HL 45692, U01HL045692)
- National Center for Research Resources (RR00046, M01RR000046)
- Topics
- Health Sciences › Medicine › Genetics (clinical) › Hemoglobinopathies and Related Disorders
- Health Sciences › Medicine › Hematology › Blood groups and transfusion
- Health Sciences › Medicine › Hematology › Hemophilia Treatment and Research
- Keywords
- hydroxyurea, sickle cell disease, vaso-occlusive crisis, fetal hemoglobin, blood transfusion, myelosuppression, treatment efficacy, adverse effects
- MeSH terms
- Adult, Anemia, Sickle Cell, Double-Blind Method, Female, Follow-Up Studies, Humans, Hydroxyurea, Male, Pain
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